eviCore is a company committed to advancing medical benefits management – and enabling better outcomes for patients, providers, and plans.

However, if you look at how it makes decisions about the guidelines it provides to its customers on the application of recent advances in the management of prostate cancer, one might feel that a different perspective was in order.

It came to our attention that eviCore has recently developed a revised set of draft guidelines on the application of imaging technologies in the management of prostate cancer. In that set of draft guidelines (see Oncology Imaging Guidelines, v. 19.0), eviCore makes a number of interesting statements.

First, the company defines the term “experimental and investigational procedure” as follows (see p. 30 of the guidance document):

An experimental or investigational procedure is generally defined as the use of a service, supply, drug or device that is not recognized as standard medical care for the condition, disease, illness or injury being treated as determined by the health plan based on independent review of peer reviewed literature and scientific data.

The “New” Prostate Cancer InfoLink certainly doesn’t define “experimental and investigational procedure” in this way. Indeed, we are entirely unclear which providers of medical services would ever define any approved medical procedure in this way. Just because a medical procedure of any type is not “standard medical care” doesn’t mean it is either “experimental” or “investigational” at all. It could just mean that it is the best thing since sliced bread but the FDA only approved it last week. Or it could mean that it is so difficult to do that it can only be used in half a dozen centers around the world … even though it is clearly an extremely good procedure. In fact, classifying a medical procedure as “investigational” or “experimental” is widely understood to be a mechanism that helps to delay the widespread acceptance of new methodologies because then they do not get covered by health insurance companies or other payers. And so, …

The eviCore guidelines then go onto state that all of the following are “investigational procedures” when applied in the diagnosis, work-up, monitoring, or treatment of prostate cancer:

The [11C]choline PET/CT scan that was approved by the FDA for use in the evaluation of men with recurrent prostate cancer at the Mayo Clinic in 2012

The [18F]fluclovine PET scan that was approved by the FDA for use in the evaluation of men with recurrent prostate cancer earlier this year

Any and all use of magnetic resonance spectroscopy in the evaluation of men with or at risk for prostate cancer, which therefore means that payers have no need to cover the costs of MRIs necessary to carry out MRI/TRUS-fusion biopsies of any type or the use of MRI to determine risk for extracapsular extension of prostate cancer prior to either surgery or radiation therapy or in the monitoring of men on active surveillance (see below)

The use of focal laser ablation (FLA)

The use of high-intensity focal ultrasound (HIFU)

They also state that current guidelines for the practice of active surveillance require every patient to be given a “Repeat biopsy every 12 months”, which has now been considered to be unnecessary by almost every competent practitioner of active surveillance for prostate cancer.

We are very willing to accept that the use of HIFU and FLA can reasonably still be defined as “investigational”. There are few good published data here in the USA on the effectiveness and safety of these two techniques. However, we would still encourage any patient considering these methods of treatment for prostate cancer to appeal any decision suggesting that these techniques are “experimental”. They are already in relatively widespread use by small numbers of experts, and so they are certainly not “experimental”.

We also wish to be equally clear that payers and insurance companies are and should be entitled to request “prior approval” of techniques such as the [11C]choline PET/CT scan and the [18F]fluclovine PET scan so that they can be reasonably sure that these tests are being given to men who meet appropriate criteria for such a test.

However, we will act in the best interests of patientss by arguing that any test that has been approved by the FDA for the diagnosis, work-up, or monitoring of men with prostate cancer is quite clearly neither experimental nor investigational. We will also act in the best interests of patients — to whatever extent we can — to ensure that thay have access to other up-to-date and appropriate forms of care that may not require further regulatory approval once sufficient data have been generated to justify such care as neither experimental nor investigational according to the normal definitions of these two terms (as opposed to the definition used by eviCore — which appears to us to have been used in order to actually deny appropriate patients access to medical techniques and procedures that already offer the chance of “better outcomes” than “standard medical care”.

Indeed, the very use of the term “standard medical care” when applied to prostate cancer is misleading. There is almost no form of “standard medical care” in the management of prostate cancer today, with the exception of the use of the PSA test to monitor risk for recurrence of prostate cancer after first-line therapy and the use of one of many forms of androgen deprivation therapy in the management of men with metastatic prostate cancer to prevent disease progression and consequent pain. There are plenty of physicians who would still consider either immediate surgery or immediate radiation therapy of some type to be “standard medical care” for the management of men diagnosed with low-risk or even very low-risk prostate cancer. That doesn’t mean it is still good practice. In most cases that would now be considered to be over-treatment. A respectable court of law would probably now consider the failure to fully inform patients with low-risk prostate cancer about the potential benefits of active surveillance to be unethical.

No one is suggesting that the FDA always “gets it right”. And Drs. Avorn and Kesselbaum have an extensive track record of being critical of the FDA from their particular academic white tower. I have to say that I cannot agree with Jon Nowlin that when the FDA approves a product it should necessarily be reimbursable by all payers, because I still believe that there is an obligation on manufacturers to demonstrate that a product or procedure is worth what the company feels like charging for it.

I would also note that the FDA has no responsibility whatsoever for what biopharmaceutical companies charge for their products. Would your reaction have been different if the company in question had decided to charge $0.50 per course of therapy for that particular product?

Disclaimer

News and information provided on this site should not be used for diagnosing or treating any health problem or disease.

The “New” Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services and is not a substitute for professional care. If you have or suspect you may have a health problem, please consult your healthcare provider.